PURPOSE: To compare gentleness of a silicone tape to a paper tape and to an untreated control. DESIGN: Controlled, randomized, grader-blinded cohort trial. SUBJECTS AND SETTING: The sample group comprised 28 healthy volunteers aged 55 years and older (median age = 63 years) with a Fitzpatrick Skin Type of I, II, or III. All volunteers were recruited from the greater Philadelphia area and the study was conducted at a dermatological research facility specializing in noninvasive instrumental measurements. METHODS: Tapes were applied and removed daily (excluding weekends) to 2 of 3 sites on the left and right volar forearms over an 11-day period. The center site on each forearm was left untreated and tapes were randomized to the proximal and distal sites. The primary assessment was transepidermal water loss (TEWL); secondary assessments included erythema/edema, denudation/skin-stripping, and subject self-evaluations. Study personnel conducting the primary and secondary assessments were not involved with treatments to maintain the blinded nature of the study. The identity of the 2 tapes was not revealed to the subjects until after conclusion of the study. RESULTS: On day 11 the mean TEWL value for the paper tape was significantly higher than that for both the untreated control and silicone tape (P < .001). End-of-study mean TEWL values were 2.65 ± 0.68 g/mh for the silicone tape, 6.85 ± 4.97 g/mh for the paper tape, and 3.73 ± 1.19 g/mh for the untreated control. At all assessments, the silicone tape exhibited net changes from baseline that were significantly less than the paper tape (P < .05 day 1, P < .001 days 4, 7, and 11) and similar for the untreated control. Only at days 4 (P < .01) and 11 (P < .001) was the paper tape significantly higher than that for the untreated control. Throughout the study, both tapes exhibited mean TEWL values within the range of normal intact forearm skin, indicating that both tapes were gentle. No differences in erythema/edema scores occurred but the silicone tape resulted in lower denudation/skin-stripping scores than the paper tape at days 4 to 11 (P < .0001). Self-assessment of pain at removal was low for both tapes but significantly lower for the silicone tape (days 1-7, P = .02; day 11, P = .009). Forty-four percent of participants expressed a preference for the silicone tape as compared to the paper tape (19%), with 37% stating no preference. CONCLUSIONS: Based on TEWL assessment of disruption of the stratum corneum water barrier, the silicone tape proved gentler to the skin than the paper tape. After 9 applications and removals over 11 days of study, the silicone tape was similar to the untreated control, whereas the paper tape exhibited significantly higher mean TEWL values than both the untreated control and the silicone tape. Expert grader assessments corroborate these findings. These data indicate that the silicone tape may provide additional gentleness when it is clinically needed.
RCT Entities:
PURPOSE: To compare gentleness of a silicone tape to a paper tape and to an untreated control. DESIGN: Controlled, randomized, grader-blinded cohort trial. SUBJECTS AND SETTING: The sample group comprised 28 healthy volunteers aged 55 years and older (median age = 63 years) with a Fitzpatrick Skin Type of I, II, or III. All volunteers were recruited from the greater Philadelphia area and the study was conducted at a dermatological research facility specializing in noninvasive instrumental measurements. METHODS: Tapes were applied and removed daily (excluding weekends) to 2 of 3 sites on the left and right volar forearms over an 11-day period. The center site on each forearm was left untreated and tapes were randomized to the proximal and distal sites. The primary assessment was transepidermal water loss (TEWL); secondary assessments included erythema/edema, denudation/skin-stripping, and subject self-evaluations. Study personnel conducting the primary and secondary assessments were not involved with treatments to maintain the blinded nature of the study. The identity of the 2 tapes was not revealed to the subjects until after conclusion of the study. RESULTS: On day 11 the mean TEWL value for the paper tape was significantly higher than that for both the untreated control and silicone tape (P < .001). End-of-study mean TEWL values were 2.65 ± 0.68 g/mh for the silicone tape, 6.85 ± 4.97 g/mh for the paper tape, and 3.73 ± 1.19 g/mh for the untreated control. At all assessments, the silicone tape exhibited net changes from baseline that were significantly less than the paper tape (P < .05 day 1, P < .001 days 4, 7, and 11) and similar for the untreated control. Only at days 4 (P < .01) and 11 (P < .001) was the paper tape significantly higher than that for the untreated control. Throughout the study, both tapes exhibited mean TEWL values within the range of normal intact forearm skin, indicating that both tapes were gentle. No differences in erythema/edema scores occurred but the silicone tape resulted in lower denudation/skin-stripping scores than the paper tape at days 4 to 11 (P < .0001). Self-assessment of pain at removal was low for both tapes but significantly lower for the silicone tape (days 1-7, P = .02; day 11, P = .009). Forty-four percent of participants expressed a preference for the silicone tape as compared to the paper tape (19%), with 37% stating no preference. CONCLUSIONS: Based on TEWL assessment of disruption of the stratum corneum water barrier, the silicone tape proved gentler to the skin than the paper tape. After 9 applications and removals over 11 days of study, the silicone tape was similar to the untreated control, whereas the paper tape exhibited significantly higher mean TEWL values than both the untreated control and the silicone tape. Expert grader assessments corroborate these findings. These data indicate that the silicone tape may provide additional gentleness when it is clinically needed.